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United States · US · US:51672-2106_28db7596-f131-dd07-e063-6294a90a5da9
Cetirizine Hydrochloride
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTaro Pharmaceuticals U.S.A., Inc.
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1151672210611 BOTTLE in 1 CARTON (51672-2106-1) / 240 mL in 1 BOTTLE
- ndc1151672210641 BOTTLE in 1 CARTON (51672-2106-4) / 60 mL in 1 BOTTLE
- ndc1151672210681 BOTTLE in 1 CARTON (51672-2106-8) / 120 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A201546
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "64O047KTOA",
"rxcui": "203150",
"inchikey": "PGLIUCLTXOYQMV-UHFFFAOYSA-N",
"display_name": "CETIRIZINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"817d07cf-5e31-421f-9e95-943bae01f5b0": {
"match": "brand_token",
"title": "CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]",
"spl_version": "8",
"published_date": "2026-06-01"
}
},
"productid": "51672-2106_28db7596-f131-dd07-e063-6294a90a5da9",
"productndc": "51672-2106",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "201546",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG/5ML",
"product_no": "001",
"approval_date": "May 20, 2011"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG/5ML",
"product_no": "002",
"approval_date": "May 20, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "Cetirizine Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA201546",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride",
"start_marketing_date": "20110520",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code R06AE.
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